Validation Manager

6 days ago


Allentown, Pennsylvania, United States Sharp Corporation Full time
Job Title: Validation Manager

Sharp Corporation is seeking a highly skilled Validation Manager to join our team. As a key member of our Quality Assurance department, you will be responsible for overseeing the validation program at our designated site.

Key Responsibilities:
  • Manage the validation program at the assigned site, ensuring compliance with regulatory requirements and company standards.
  • Develop and implement validation plans, protocols, and reports to support project schedules.
  • Supervise the execution and summarization of validation activities, including packaging, cleaning, HVAC, and computer system validation.
  • Guide validation engineers in the development of new test scripts and ensure adherence to quality engineering practices.
  • Develop, maintain, and improve key performance metrics for all areas of responsibility, publishing metrics on a monthly basis.
  • Design and implement proficiency training for all areas of responsibility, ensuring alignment with Sharp Compliance requirements.
  • Participate in customer or regulatory audits, assisting in the audit response and monitoring commitments related to validation issues.
Requirements:
  • Bachelor's degree in a technical discipline (BS/BA) from a four-year college or university, with five to ten years of related experience and/or training.
  • Independent certification of advanced quality skills and practices (e.g., ASQ, CQE, Six Sigma) is desired.
  • Broad knowledge of current validation principles and industry practices, including FDA regulations, cGMPs, and validation guidance documents.
  • Familiarity with quality engineering practices in manufacturing operations and basic engineering principles and practices.
  • Ability to multi-task, independently plan and schedule validation activities, and commit to meeting project deadlines.
Working Environment:

The Validation Manager will work in a clean and safe environment, with approximately 10% travel between Sharp sites and to off-site assignments. The ideal candidate will be able to work effectively in a team environment, communicate professionally with internal and external stakeholders, and maintain confidentiality when handling sensitive information.

Sharp Corporation is an equal opportunity employer and welcomes applications from diverse candidates. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.


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